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A Phase 2, Double-Blind, Randomized, Placebo-Controlled Multicenter Study to Evaluate the Efficacy and Safety-Tolerability of a Single Oral Dose of EP102 Self-Administered at Home by Adult Participants Experiencing Moderate-To-Severe Migraine Headache

A Phase 2, Double-Blind, Randomized, Placebo-Controlled Multicenter Study to Evaluate the Efficacy and Safety-Tolerability of a Single Oral Dose of EP102 Self-Administered at Home by Adult Participants Experiencing Moderate-To-Severe Migraine Headache

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12625000333415
Enrollment
242
Registered
2025-04-17
Start date
2025-10-03
Completion date
2027-04-09
Last updated
2026-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The primary purpose of the study is to assess the safety and tolerability of a single oral dose of EP102 600 or 400 mg self-administered at home by adult participants experiencing moderate-to-severe migraine headache.

Interventions

Participants with receive a bottle of investigational product (IP) containing two oral capsules. The bottle of the investigational product will contain either: • EP102: 2 capsules, each containing 200 mg of EP102 (total of 400 mg of EP102-04) • EP102: 1 capsule containing 200 mg of EP102 and 1 capsule containing placebo (total of 200 mg of EP102-04) • Placebo: 2 capsules, each containing placebo ( no active medication) Participants will visit the clinical trial centre three (3) times in total:

Participants with receive a bottle of investigational product (IP) containing two oral capsules. The bottle of the investigational product will contain either: • EP102: 2 capsules, each containing 200 mg of EP102 (total of 400 mg of EP102-04) • EP102: 1 capsule containing 200 mg of EP102 and 1 capsule containing placebo (total of 200 mg of EP102-04) • Placebo: 2 capsules, each containing placebo ( no active medication) Participants will visit the clinical trial centre three (3) times in total: • Visit 1 - a screening visit to see if you are eligible for the trial • Visit 2 - for a final eligibility check and for administration of a test-dose of the investigational product • Visit 3 - 3-10 days after the participant has self-administered the investigational product at home Single oral dose of EP102 200, EP102 400 mg, or placebo will be administered as a test dose in the clinic while the participant is not experiencing a migraine attack. This is being conducted to assess the safety and tolerability of a single oral dose of EP102 200 mg or EP102 400 mg. This will be evaluated by the collecting of adverse events, changes in vital signs, oxygen saturation, and results of orthostatic testing. If orthostatic hypotension is diagnosed after randomization at Visit 2 at the test dose the participant is to be withdrawn from the study. Randomized participants will have up to 45 days after the randomization visit (Visit 2) to treat a qualifying migraine headache of at least moderate pain severity with the assigned blinded IP. Participants will be instructed to store the bottles in a cool dry place outside of direct sunlight. Participants are to bring their IP bottles with them to the end-of-study visit for IP accountability. Participants must agree to adhere to clinic visits and all other requirements of the study.

Participants with receive a bottle of investigational product (IP) to take home. Each bottle will contain three oral capsules. The bottle of the investigational product will contain either: • EP102: 3 capsules, each containing 200 mg of EP102 (total of 600 mg) or • Placebo: 3 capsules, each containing placebo (no active medication) Participants will visit the clinical trial centre three (3) times in total: • Visit 1 - a screening visit to see if you are eligible for the trial • Visit 2 - for a

Participants with receive a bottle of investigational product (IP) to take home. Each bottle will contain three oral capsules. The bottle of the investigational product will contain either: • EP102: 3 capsules, each containing 200 mg of EP102 (total of 600 mg) or • Placebo: 3 capsules, each containing placebo (no active medication) Participants will visit the clinical trial centre three (3) times in total: • Visit 1 - a screening visit to see if you are eligible for the trial • Visit 2 - for a final eligibility check and for administration of a test-dose of the investigational product • Visit 3 - 3-10 days after the participant has self-administered the investigational product at home A single oral dose of EP102 600 mg or placebo will be administered as a test dose in the clinic while the participant is not experiencing a migraine attack. This is being conducted to assess the safety and tolerability of a single oral dose of EP102 600 mg. This will be evaluated by the collecting of adverse events, changes in vital signs, oxygen saturation, and results of orthostatic testing. If orthostatic hypotension is diagnosed after randomization at Visit 2 at the test dose the participant is to be withdrawn from the study. Randomized participants will have up to 45 days after the randomization visit (Visit 2) to treat a qualifying migraine headache of at least moderate pain severity with the assigned blinded IP. Participants will be instructed to store the bottles in a cool dry place outside of direct sunlight. Participants are to bring their IP bottles with them to the end-of-study visit for IP accountability. Participants must agree to adhere to clinic visits and all other requirements of the study.

Sponsors

Epalex Australia
Lead SponsorCommercial sector/Industry

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

Age 18 to 65 years at the time of signed informed consent Age at onset of migraine attacks 1 year History of 2 to 8 migraine attacks with moderate or severe pain on average per month for the 3 months prior to the screening visit Fewer than 15 days with headaches (migraine or non-migraine) per month for the 3 months prior to the screening visit Body weight 50.0 kg to 100 kg Body mass index (BMI) 18.0 to 35.0 kg/m2

Exclusion criteria

History of hemiplegic migraine (at any time in the past) History of both tension-type headaches, and migraine and participant is unable to distinguish between them Major surgery within 6 months prior to screening, Diagnosis of sleep apnoea Recurrent syncope (vasovagal or other) Overuse of medications for migraine or other conditions during the 3 months prior to screening =10 days/month for 3 months Opioids (narcotics) Triptans Benzodiazepines, barbiturates, sleeping aids iHerbal supplements and natural health products used for acute treatment of migraine =15 days/month for 3 months Simple analgesics (e.g., aspirin, NSAIDs, paracetamol

Outcome results

None listed

Source: ANZCTR · Data processed: Jul 23, 2026